System and method for low-power laser treatment of adipose cells

ABSTRACT

A lipolysis system comprises a laser applicator that contacts a subject&#39;s body surface and provides laser irradiation thereto in communication and cooperation with a laser control device. The laser applicator is controlled to provide low-power laser irradiation to a targeted portion of a subject&#39;s body surface for the purpose of liquefying fats in adipose cells in the subcutaneous region underlying the contacted portion of the body surface. A method for liquefying fats in a subject&#39;s adipose cells comprises contacting a portion of a subject&#39;s body surface with a laser applicator and controllably irradiating a target portion with laser wavelengths for a selected period of time. Laser applicators in one embodiment comprise low-power laser diodes having power outputs in the range of 10 mW to 100 mW with light waves in the range of 635 nm to 680 nm.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a division of application Ser. No. 11/860,457 filedSep. 24, 2007, which is a continuation-in-part of U.S. application Ser.No. 11/577,356 filed on Apr. 17, 2007, which is a national phase filingunder 35 U.S.C. §371 of international application numberPCT/KR2006/000694, filed Feb. 28, 2006, which claims priority fromKorean application number 10-2006-0015778, filed Feb. 17, 2006, andKorean application number 10-2005-0017330, filed Mar. 2, 2005. Theentire content of each of these prior applications are incorporatedherein by reference in its entirety.

TECHNICAL FIELD

The present invention relates to low-power laser irradiation of skinsurfaces for lipolysis of underlying adipose cells. More particularly,this invention relates to low-power laser applicators, systemscomprising the laser applicators, and methods for their use in providinglipolysis treatments.

BACKGROUND OF THE INVENTION

Various apparatuses are known for providing a curative effect byirradiating spots on a patient's body with low-power insertable laserdevices. Such apparatus are generally configured with one or more laserdiodes configured for emitting outputs in the range of 5 mW to 10 mW andwavelengths in the range of 635 nm to 650 nm, and a low power laserdiode driver for arbitrarily adjusting the amount of laser beam emittedfrom the on or more laser diodes.

For example, Korean Utility Model No. 302173 discloses an electric matfor uniformly emitting a laser beam through a low power laser diode.Korean Utility Model No. 270882 discloses a waist belt including a lasergenerator having a laser diode for emitting laser light having awavelength of 580-980 nm to stimulate the lumbar, thereby performingfinger-pressure treatment and therefore medical treatment of a disc.Korean Utility Model No. 274266 discloses a laser for medical treatmentand an LED blanket capable of widening a curative range, for example,irradiation of spots on the body suitable for acupuncture, chronicarticle rheumatism, frozen shoulder, lumbago, cervical vertebral sprain,gout, wrench, bruising, arthritis, stress gastritis, and so on. KoreanPatent No. 457964, issued to the present applicant, discloses a laserbeam radiator capable of non-invasively irradiating blood in a bloodvessel with a laser beam according to a position and a thickness of theblood vessel by adjusting a distance of the laser beam condensed throughan optical lens, activating metabolism of a cell by stimulating a bloodcell using a laser beam, increasing formation of capillary vessels toimprove blood circulation, and increasing speed of tissue treatment toactivate living organisms.

While another laser apparatus using a laser beam disposed in an arrayfor providing use convenience is proposed to be adapted to various softmaterials such as a chair, a hat, a bed, a belt, and so on, when thelaser beam is disposed in the soft materials in an array, a red lasercapable of being output appropriately to non-invasively break down fat(about, more than 30 mW) should be used. However, since the red laserrequires a separate radiation structure, there is no way of breakingdown fat by non-invasively irradiating a human body.

Meanwhile, in order to effectively treat obesity using a laser, Neira etal. (2002, Plastic and Reconstructive Surgery 110(3): 912-922) disclosea process for liquefying fat by waving a low-power laser back and forthsix inches above a subject's abdomen and then removing the liquefied fatwith a surgical liposuction i.e., lipectomy procedure. Neira et al.'spaper is based on a test in which lasers having a wavelength of 635 nm,an output of 10 mW, and a total energy of 1.2 J/cm², 2.4 J/cm² and 3.6J/cm² are radiated onto adipose tissue extracted from 12 healthy women.As a result of the test, 4 minutes after laser exposure, 80% of the fatin the adipose cells is discharged, and 6 minutes after the laserexposure, 99% is discharged. It was reported that energy of the lowpower laser acts to open a cell wall to discharge fat from the interiorto the exterior of the adipose cell. Then, the discharged fat isgathered in a space between the adipose tissues. Using the fatliquefaction effect of the red laser on the basis of the test, suctionlipectomy using a laser, in which the human body is irradiated fromoutside to break down fat and discharge the broken down fat from thebody using a cannular (fine pipe), has been proposed.

Various methods of non-invasively irradiating skin covering a fatty areaof a treatment target with a red laser beam to break down the fat of theadipose cells have been attempted. In order to irradiate a wider areafor a short time, a device for forming a red laser beam with a lineshape to scan the treatment target has been developed and put on themarket. However, it is difficult to input a power of 10 mW and an energydensity of 3.6 J/cm² required for lipolysis in the human body, therebyobtaining little practical effect.

SUMMARY OF THE INVENTION

The exemplary embodiments of the present invention are directed to laserapplicators, systems comprising the laser applicators, and methods fortheir use for liquefaction of fats in adipose cells for removal intointerstitial spaces wherefrom they are removed from a subject's body bytheir normal physiological processes.

According to one exemplary embodiment, there is provided a laserapplicator having at least one low-power light-emitting laser diode. Asuitable low-power light-emitting laser diode is one that emits poweroutputs in the range comprising about 10 mW to about 100 mW with lightwaves in the range of 635 nm to 680 nm. The laser applicator isconfigured for contacting a subject's body surface for application oflow-power laser irradiation. The laser applicator is configured tocommunicate and cooperate with a laser control device comprising a powersupply device, circuitry interconnecting software-controllableelectronic devices configured for at least one of generating,transmitting, recording, processing, storing and reporting electronicsignals useful for manipulable modulation of the output from the powersupply device for generation of laser light waves. The low-power laserirradiation causes liquefaction of fats in adipose cells in thesubcutaneous portions of the subject's body underlying the surfacecontacted by the laser applicator. The liquefied fat is discharged fromthe adipose cells into the interstitial areas between the cells fromwhich it is absorbed by the subject's lymphatic system and removed fromtheir body with their normal physiological processes.

According to one aspect, the laser applicator comprises a plurality oflow-power light-emitting diodes.

According to another aspect, the laser applicator is provided with aplurality of low-power light-emitting diodes each selected for emissionof power outputs in the range comprising about 10 mW to about 100 mWwith light waves in the range of 635 nm to 680 nm, and a plurality ofmedium power laser diodes having power outputs in the range of about 80mW to about 160 mW with light waves in the range of 780 nm to 980 nm.

According to another aspect, the laser applicator comprises a printedcircuit board provided with a power connector for communicating with acontroller device, a contact plate formed of a hard plate configured forcooperating with the PCB and having at least one transparent window or alens disposed at one side surface, at least on low-power light-emittinglaser diode inserted into the at least one transparent window or lensdisposed on the contact plate and electrically connected to the PCB; anda framework or alternatively, a housing for accommodating and retainingtherein the laser printed circuit board, contact plate and laser diode.The housing is suitable configured for contacting the at least onetransparent window or lens of the contact plate in close contact withthe skin during application of laser irradiation of the skin andunderlying subcutaneous region.

According to a further aspect, the contact plate may comprise a flexiblematerial.

According to a yet further aspect, a plate of heat-absorbing materialmay be interposed the contact plate and the printed circuit board. Theplate of heat-absorbing material may be configured to communicate andcooperate with a cooling device.

According to another aspect, the surface of the contact plate may becoated with a thermal interface material.

According to another exemplary embodiment of the present invention,there is provided a lipolysis system comprising at least one laserapplicator provided with at least one low-power laser diode selected foremission of power outputs in the range comprising about 10 mW to about100 mW with light waves in the range of 635 nm to 680 nm, and a lasercontrol device provided with hardware, circuitry and software configuredfor at least one of generating, transmitting, recording, processing,storing and reporting electronic signals useful for manipulablemodulation of the output from the power supply device for generation oflaser light waves. The at least one applicator is configured forcontacting a portion of a subject's body surface for controllably andmanipulably providing laser light irradiation thereto for the purpose ofliquefying fats in adipose cells in the subcutaneous region underlyingthe portion of the subject's body surfaces contacted by the laserapplicator.

According to one aspect, the laser applicator is provided with aplurality of low-power laser diodes each selected for emission of poweroutputs in the range comprising about 10 mW to about 100 mW with lightwaves in the range of 635 nm to 680 nm.

According to another aspect, the laser applicator is provided with aplurality of low-power light-emitting diodes each selected for emissionof power outputs in the range comprising about 10 mW to about 100 mWwith light waves in the range of 635 nm to 680 nm, and a plurality ofmedium-power laser diodes each having power outputs in the range ofabout 80 mW to about 160 mW with light waves in the range of 780 nm to980 nm.

According to another aspect, the laser applicator housing may beconfigured to contact a larger portion of a subject's body surface suchas an abdomen, the lower back area, hips, and buttocks. The housing andcontact plate provided in this embodiment are suitably concave. Thecontact plate may optionally comprise a flexible material.

According to yet another aspect, the laser applicator housing oralternatively the framework, may be provided with hinges on its oppositeends thereby making it possible to interlink two or more such hingedlaser applicators together. Accordingly, the two or more interlinkedlaser applicators may be controllably maneuvered to provide excellentcontact of larger portions of a subject's body surface with the contactplates having disposed therein laser diodes.

According to another exemplary embodiment of the present invention,there are provided methods for the use of the lipolysis systems of thepresent invention for liquefying fats in subcutaneous adipose cells. Anoperator contacts the contact plate of the at least one laser applicatorwith a target portion of a subject's body surface after which theoperator manipulates the control device to provide laser lightirradiation of the target portion of the subject's body portion for aselected period of time during which the laser light causes liquefactionof fats in adipose cells in the subcutaneous region underlying thetarget body portion. The liquefied fats are discharged from the adiposecells into the interstitial spaces wherefrom the liquified fats areremoved from the subcutaneous regions underlying the target portions bythe subject's lymphatic system. It is suitable during a lipolysistreatment session to contact the at least one laser applicator withmultiple target portions of a subject's body surface for application oflaser irradiation thereto.

According to another exemplary embodiment of the present invention,there is provided a vacuum suction device configured to sealably engageand cooperate therewith a laser applicator of the present invention. Thevacuum suction device is suitably configured with an inner bowl-shapedchamber having an outer rim configured for sealingly engaging a targetportion of a subject's body surface. The apex of the bowl-shaped chamberis configured to sealingly engage and communicate with the contact plateof the laser applicator, and to transmit therethrough laser irradiationgenerated by the at least one laser diode of the laser applicator. Thevacuum suction device is interconnected to a controllable vacuum pump.

According to one aspect, the vacuum suction device is configured tosealingly engage and cooperate with a laser-generating device comprisinga low-power laser diode selected for emission of power outputs in therange comprising about 10 mW to about 100 mW with light waves in therange of 635 nm to 680 nm.

According to another aspect, the vacuum suction device is provided withat least one pressure release aperture configured for engagement anddisengagement by an operator's finger.

According to another exemplary embodiment of the present invention,there is provided a lipolaser system comprising a vacuum suction deviceconfigured to cooperate with a laser applicator of the present inventionor alternatively with a laser generating device, an exemplary laserapplicator of present invention or alternatively a laser generatingdevice, and a controllable vacuum pump cooperatively interconnected tothe vacuum suction device.

According to one aspect, the vacuum pump is controllably and manipulablyinterconnected to a plurality of vacuum suction devices.

According to another exemplary embodiment, there are provided methodsfor the provided methods for the use of the lipolysis systems comprisingthe vacuum suction devices of the present invention for liquefying fatsin subcutaneous adipose cells. An operator contacts the outer rim of thevacuum suction device with a target portion of a subject's body surfaceafter which the operator activates the vacuum pump and manipulates thelaser control device to provide laser light irradiation of the targetportion of the subject's body portion for a selected period of timeduring which the laser light causes liquefaction of fats in adiposecells in the subcutaneous region underlying the target body portion. Theliquefied fats are discharged from the adipose cells into theinterstitial spaces wherefrom the liquified fats are removed from thesubcutaneous regions underlying the target portions by the subject'slymphatic system. It is suitable during a lipolysis treatment session tocontact the at least one laser applicator with multiple target portionsof a subject's body surface for application of laser irradiationthereto.

According to one aspect, an operator may impose and release suctionforce within the vacuum suction device by engaging and disengaging thepressure release aperture with their finger. The vacuum suction devicemay be moved about a subject's body surface while the pressure releaseaperture is disengaged.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be described in conjunction with reference tothe following drawings, in which:

FIG. 1 is an exploded perspective view of a laser applicator of anexemplary lipolysis system according to one embodiment of the presentinvention;

FIG. 2 is a plan view of a laser irradiation distribution range of anexemplary laser applicator according to another embodiment of thepresent invention;

FIG. 3 is a perspective view of an exemplary laser applicator systemaccording to the present invention;

FIG. 4 is a perspective view of another exemplary laser applicatorsystem according to the present invention;

FIG. 5 is a cross-sectional schematic side view of another exemplarylaser applicator system according to the present invention;

FIG. 6 is a cross-sectional side view of another exemplary embodiment ofa laser applicator system according to the present invention;

FIG. 7 is an exploded perspective view of the embodiment shown in FIG.6;

FIG. 8 is a schematic diagram of an exemplary expanded laser applicationsystem according to the present invention, comprising a plurality ofcooperating embodiments exemplified in FIGS. 6 and 7;

FIG. 9 is a schematic view of an exemplary lipolysis system providedwith a plurality of two types of laser applicators according to thepresent invention;

FIG. 10A is a side view of one type of laser applicator of the lipolysissystem shown in FIG. 9;

FIG. 10B is an end view of the laser applicator shown in FIG. 10A;

FIG. 10C is a perspective view of the laser applicator shown in FIG.10A;

FIGS. 11A, 11B, and 11C are schematic illustrations of exemplarypositioning of the laser applicators of the lipolysis system shown inFIG. 9, about a subject's body torso for liquefaction of fats abouttheir waistline;

FIGS. 12A, 12B, and 12C are schematic illustrations of exemplarypositioning of the laser applicators about a subject's body torso forliquefaction of fats about their abdominal oblique muscle areas;

FIGS. 13A, 13B, and 13C are schematic illustrations of exemplarypositioning of the laser applicators about a subject's body torso forliquefaction of fats about their upper abdominal areas;

FIGS. 14A, 14B, 14C, and 14D are schematic illustrations of exemplarypositioning of the laser applicators about a subject's body torso forliquefaction of fats about their upper thigh areas;

FIGS. 15A, 15B, 15C, and 15D are schematic illustrations of exemplarypositioning of the laser applicators about a subject's body torso forliquefaction of fats about their lower back areas;

FIG. 16 is a chart showing a comparison of waistline girth loss betweensubjects receiving laser treatments (□) and placebo treatments (▪);

FIG. 17 is a chart showing, first, the average waistline girth lossduring each laser treatment session, and second, the average waistlinegirth loss over the course of the combined treatment period; and

FIG. 18 is a chart showing a comparison of “blinded” appearance ratingassessments performed on subjects receiving laser treatments (□) andplacebo treatments (▪), first, after each treatment session, and second,the averaged cumulative ratings at the end of the combined treatmentperiod.

DETAILED DESCRIPTION OF THE INVENTION

Exemplary embodiments of the present invention provide laser applicatorsfor contacting and controllably irradiating portions of a subject's bodysurfaces with low-power lasers, systems comprising one or more of thelaser applicators cooperating with a suitable control devices forcontrollably generating laser irradiation from the laser applicators,and methods for the use of the systems for liquefaction of fat inadipose cells underlying the body surfaces for removal from theirradiated portions by the subject's physiological processes.

An exemplary laser-applicator 10 of the present invention is illustratedin FIG. 1. The laser applicator 10 generally comprises a printed circuitboard (PCB) 12 provided with a power connector 11 for receiving power,and a contact plate 14 configured to communicate and cooperate with thePCB 12. The contact plate 14 is provided with one or more selectivelyspaced-apart transparent windows or alternatively lenses 13 disposed onthe surface opposite the surface that contacts the PCB 12. One or morelaser diodes 15 are inserted into selected transparent windows or lenses13 disposed on the contact plate 14, and is electrically connected tothe PCB 12. A plurality of fastening holes 17 a and 17 b are provided atselected locations on the PCB board 12 and the contact plate 14 toenable securing of the PCB 12 to the contact plate 14 with a pluralityof fasteners 16. As shown in FIG. 1, the laser applicator 10 may beassembled by inserting the laser diodes 15 into the transparent windowsor lenses 13 of the contact plate 14, then securing the contact plate 14to the PCB 12 with a plurality of the fasteners 16. Although FIG. 1shows the laser applicator 10 configured with four laser diodes 15, itis within the scope of this invention to provide laser applicatorshaving one laser diode or alternatively, a selectable plurality of laserdiodes. The laser applicator 10 is interconnectable through the powerconnector 11 to a laser control device (not shown) comprising a powersupply device, circuitry interconnecting software-controllableelectronic devices configured for at least one of generating,transmitting, recording, processing, storing and reporting electronicsignals useful for manipulable modulation of the output from the powersupply device for generation of laser light waves.

It is suitable to encase the laser applicator 10 within a housingstructure (not shown) configured to expose at least the transparentwindows or lenses of the contact plate 14, and to provide suitablecontact for the contact plate 14 with a subject's body surface. It ispreferable that the housing structure is also configured forgraspability and ease-of-handling by an operator and for a subject'scomfort when the laser applicator 10 is in contact with a portion oftheir body surface. Alternatively, as illustrated in FIG. 2, a laserapplicator according to the present invention may comprise a housing orframework 30 provided for containing a PCB (not shown) cooperativelyassembled with a contact plate 14 configured with a large plurality oflaser diodes 15.

While the plurality of laser diodes 15 shown in FIGS. 1 and 2 areuniformly disposed within the contact plate 14, it is also within thescope of the present invention to dispose a selected number of laserdiodes 15 in an irregular pattern about the contact plate 14.Furthermore, although an elongate contact plate 14 is illustrated inFIGS. 1 and 2, it is also within the scope of the present invention toprovide contact plates having alternative shapes such as circular,elliptical, sigmoidal, obround, gibbous and the like, configured toenhance the comfort of a subject when the laser applicator 10 iscontacting a portion of their body surface.

Suitable laser diodes for incorporation into the laser applicators ofthe present invention are capable of producing power outputs in therange comprising about 10 mW to about 100 mW with light waves in therange of 635 nm to 680 nm, i.e., commonly referred to by those skilledin this art as low-power light-emitting laser diodes. When one or moreof such low-power laser diodes is/are contacted with a subject's bodysurface, the emitted light waves will penetrate through the epidermaland dermal skin layers into the subcutaneous regions which are primarilycomposed of adipose cells. The energy of low-power light wavespenetrating into the adipose cells causes liquefaction of solid andsemi-solid fat deposits contained in the adipose cells. The liquefiedfats are then easily translocated out of the adipose cells into theinterstitial spaces from where they are removed by the subject'slymphatic system and discharged from the subject's body by their normalphysiological processes.

A possible consequence of providing arrays with large pluralities oflow-power laser diodes is that considerable amounts of heat may begenerated from the laser diodes during prolonged application of laserlight energy to a subject's body portion thereby causing somediscomfort. Therefore, it is within the scope of the present inventionto provide a plate of heat-absorbing material interposed the contactplate 14 and the PCB 12 to absorb heat generated by the bases of thelow-power laser diodes, and configured to disperse the heat toward andfrom the rear of the laser applicator. Alternatively, the plate of heatabsorbing material may be configured to communicate and cooperate with acooling device for controllably removing heat generated by the low-powerlaser diodes while cooling the contact plate 14. Alternatively, thesurface of the contact plate 14 opposite the PCB board 12 may be coatedwith a thermal interface material.

It is particularly useful to configure a laser applicator comprising atleast one extended array of closely placed together plurality oflow-power laser diodes for contacting a subject's body surface therebyenabling the irradiation of larger surface areas. The consequence is amore uniform irradiation of larger areas of adipose cells resulting inmore substantial amounts of fat liquefaction and removal from the bodyportions contacted by the laser applicator, thus making it possible toselectively reduce the extent of fat-induced protuberances about asubject's body. FIG. 3 illustrates another exemplary laser applicator 50provided with a concave contact plate 54 fitted into concave curvilinearframework 56 configured to at least partially encircle larger areas of asubject's body such as the abdomen, lower hips, buttocks, and upperthigh areas. The opposite ends of the framework 56 are provided withhandles 57, to enable easy handling and positioning of the laserapplicator 50 about the subject's body portions by an operator. For suchlaser applicators, it is suitable for the contact plate 54 to comprise aflexible material that is capable of conforming to the contours of thesubject's body portions onto which the laser applicator is positioned.Alternatively, the contact plate 54 may comprise a stiff material thatmay be molded into a selected configuration suitable for applicationonly to a selected target body portion. The exemplary laser applicator50 illustrated in FIG. 3 may be placed and positioned by an operatoronto a subject who is in a prone position lying on their back oralternatively, on their stomach. However, it is optional to provide avertical support 59 fitted with a vertically adjustable positioningdevice 58 configured to engage the laser applicator 50. The subject canthen in a standing position contact a selected body portion with thelaser applicator 50 after the positioning device 58 has been adjusted toprovide optional contact between the subject's body portion and thelaser applicator 10. Those skilled in these arts will understand thatthe vertically adjustable positioning device 58 may be optionallyprovided with a pivoting component (not shown) for enabling the rotationof the laser applicator from a horizontal plane to a vertical plane. Itis also within the scope of the present invention to incorporate a lasercontrol device components into the positioning device 58.

FIG. 4 is a perspective view of an alternative embodiment of a laserapplicator 60 comprising three interconnected hinged sections 66, 66′,66″ that can be adjusted to encompass larger portions of a subject'sbody surface regardless of the extent of protuberations caused byexcessive accumulations of solid and semi-solid fats in the adiposecells underlying the larger portions of the body surface. In thisexemplary embodiment, a primary section 66 comprising a housing fittedwith a flat elongate contact plate 64 having a plurality of laser diodes65, is provided with a hinge 62 disposed at each of its opposite ends. Afirst secondary section 66′ is fitted with a flat contact plate 64′having a plurality of laser diodes 65′, and has one end configured forhinged communication and cooperation with a first hinge 62. A secondsecondary section 66″ also fitted with a flat contact plate (not visiblein this view) having a plurality of laser diodes (not visible in thisview), has one end configured for hinged communication and cooperationwith the other hinge 62′. It is suitable for the first and secondsecondary sections 66′ and 66″ to be provided with handles 67 on theends opposite their hinged ends. The hinges 62, 62′ enable pivotableadjustment of the first and second secondary sections 66′, 66″ about theprimary section 66 thus enabling an operator to fit the laser applicator60 to a subject's body portion while they are lying in a prone positionon a suitable support, and thereby provide excellent contact betweeneach of the hinged sections 66, 66′, 66″ and the body portion regardlessof the contours and extent of protuberations caused by excessive solidand semi-solid fat content in the underlying adipose cells.Consequently, the application of low-power laser irradiation to asubject's body portion by this embodiment of the laser applicator of thepresent invention will provide exceptional liquefaction of the solid andsemi-solid fat content in the underlying adipose cells. Although FIG. 4illustrates that the three hinged sections 66, 66′, 66″ are rectangular,is within the scope of the present invention to provide various suitableshapes such as circular, elliptical, sigmoidal, obround, gibbous and thelike, that are hingedly interconnectable to enhance the comfort of asubject when the laser applicator 60 is contacting a portion of theirbody surface. Further more, it is suitable to provide a primary section66 configured with a first shape e.g., rectangular, and secondarysections 66′, 66″ configured with one or more other types of shapes. Thesecondary sections may be symmetrically paired or alternatively,asymmetrically paired. It is to be understood that effective lipolysistreatments comprising liquefaction of solid and semi-solid fats inadipose cells may be provided by a laser applicator comprising a pair ofhingedly interconnected sections, each section comprising at least aPCB, a contact plate, a laser diode, a framework, a suitable housing andcooperating hinge components. Alternatively, effective lipolysistreatments may be provided by a laser applicator comprising more thanthree hingedly interconnected and sections configured as describedabove. It is suitable to configure one of the sections, e.g. a primarysection exemplified in FIG. 4, for engaging a vertically adjustablepositioning device 68 communicating and cooperating with a verticalsupport 69, to enable able a subject to contact a selected body portionwith the contact plates while in a standing position. Those skilled inthese arts will understand that the vertically adjustable positioningdevice 68 may be optionally provided with a pivoting component (notshown) for enabling the rotation of the laser applicator from ahorizontal plane to a vertical plane. It is also within the scope of thepresent invention to incorporate a laser control device components intothe positioning device 68.

The present invention also provides devices configured to cooperate withlaser applicators exemplified in FIGS. 1 and 2 to facilitatesubcutaneous delivery of lipolysis treatments for liquefaction of solidand semi-solid fats in adipose cells. One such exemplary device isillustrated in FIG. 5 and is generally configured to cooperate withlaser applicators such as those exemplified in FIGS. 1 and 2, for theapplication of negative suction forces to a portion of a body surfaceconcurrent with laser irradiation of the subcutaneous region underlyingthe body surface. The vacuum suction device 70 comprises a moldedcylindrical body 71 defining an inner bowl area 72 and is provided witha molded base 73 having an outward-extending receptacle 74 in the apexregion of the molded body for receiving and sealably retaining therein alaser applicator 40 for example as exemplified in FIG. 2 and generallyconfigured with housing into which are fitted a PCB, a contact plate,and a plurality of laser diodes each communicating with a transparentwindow or lens provided therefor in the contact plate. The molded base73 of receptacle 74 is provided with ports configured to communicatewith the contact plate's transparent windows or lens of the laserapplicator 40 thereby providing irradiation routes for the laser lightwaves from the laser applicator 40 to the body surface portion 79contained within the area defined by the rim 75 of the molded body 71. Avacuum port 76 communicating with the inner bowl area 72 is provided onthe outer surface of the molded body 71. The vacuum port 76 isconfigured to sealing engage a vacuum line 77 interconnected to a vacuumpump 78.

An exemplary method for the use of the laser applicator 40 incombination with the suction device 70 illustrated in FIG. 5, comprisessealably installing the laser applicator 40 into the receptacle 74 inthe base of the molded bowl 72, then interconnecting the laserapplicator 40 to a suitable control device (not shown) comprising atleast a power supply device, circuitry interconnectingsoftware-controllable electronic devices configured for at least one ofgenerating, transmitting, recording, processing, storing and reportingelectronic signals useful for manipulable modulation of the output fromthe power supply device for generation of laser light waves. The suctiondevice 70 is then placed onto a subject's body surface portion targetedto receive the lipolysis treatment so that the entire rim 75 surface isin contact with the subject's skin. The vacuum pump 78 is then engagedthereby applying a suction force through the vacuum line 77 and vacuumport 76 to the inner bowl area 72. The suction force draws the subject'sbody surface toward the base area 73 of the molded bowl 72 so that it isin close proximity to the laser diodes of the laser applicator 40. Thelaser control device is then manipulably operated to generate selectedamounts of laser energy from the range of 10 mW to 100 mW by the laserdiodes 15 for irradiation of the body portion that is drawn by thesuction force within the inner bowl area 72. The laser irradiationpenetrates into the subcutaneous region of drawn-in body portion andliquefies solid and semi-solid fats in the adipose cells therein. Thesuction force exerted on the body portion facilitates the movement ofthe liquefied fat from the adipose cells into the interstitial spacesfrom where it is absorbed into the lymphatic system and removed from thebody portion by the subject's normal physiological processes.

Another exemplary laser applicator system according to the presentinvention is illustrated in FIGS. 6 and 7 and generally comprises amolded bowl-shaped suction device 90 configured to releasably engage andcooperate with a low-power generating laser module 80. Thelaser-generating module 80 generally comprises a PCB 81 configured forreceiving power, a low level light-emitting laser diode 82 with a poweroutput in the range comprising about 10 mW to about 100 mW with lightwaves in the range of 635 nm to 680 nm electrically connected to the PCB81, a transparent window or lens 83 disposed adjacent to the laser diode82, upper and lower fixtures 84 and 85 for accommodating the PCB 81, thelaser diode 82, and the transparent window or lens 83, which aredetachable from each other, and a cover 86 installed outside the upperand lower fixtures 84 and 85. A male-threaded part 84 a and afemale-threaded part 85 a are provided at a lower periphery of the upperfixture 84 and an upper periphery of the lower fixture 85 to bethreadedly engaged with each other, a hooking threshold 84 b is formedat an inner periphery of the upper fixture 84 to be engaged with the PCB81, and a groove 85 b is formed at a lower periphery of the lowerfixture 85 to be engaged with the transparent window or lens 83. Aselected interval between the laser diode 82 and the transparent windowor lens 83 can be controllably provided by progressively engaging ordisengaging the male threaded part 84 a and the female threaded part 85a formed at the upper and lower fixtures 84 and 85. The PCB 81 isconnectable to a cable 81 a to receive power, and an insertion hole 86 afor inserting the cable 81 a therethrough, is provided at an upper partof the cover 86.

The bowl-shaped suction device 90 comprises a body 91 provided with acontinuous outer rim having a molded lip 93. The outward-extendingsurface portion of the molded lip 93 may be optionally provided with acontinuous channel 94 configured to receive and cooperate with a ring 95comprising a suitable resilient material. Alternatively, the continuouschannel 94 may be configured to receive and cooperate with a pluralityof balls (not shown). A vacuum port 97 communicating with the inner bowlarea 92 with line 96 is provided on the outer surface of the molded body91. The vacuum port 92 is configured to sealing engage a vacuum line 98interconnected to a vacuum pump 100. An upward extending coupler portion99 is provided at the apex of the body 91, with a bore therethrough themolded body 91 for receiving and sealingly engaging the laser module 80.In order to sealably engage the suction device 90 and thelaser-generating module 80, female and male threaded parts 83 and 86 bare formed about the inner upper section of the bore extending throughthe upper section of the coupler portion 99 and an outer periphery ofthe cover 86. Further, the upper and lower fixtures 84 and 85 may beformed of a thermal interface material for radiating heat generated fromthe laser diode 82 of the laser-generating module 80. An intervalbetween the laser diode 82 and the transparent window or lens 83 can beadjusted by first separating the cover 86 from the laser diode 82, thencontrollably engaging or disengaging the male threaded part 84 a and thefemale threaded part 85 a formed at the upper and lower fixtures 84 and85.

An exemplary method for the use of the laser applicator 80 incombination with the suction device 90 illustrated in FIGS. 6 and 7,comprises sealably installing the laser-generating module 80 into thecoupler 99 at the apex of the molded body 91, then interconnecting thelaser generating module 80 to a suitable control device (not shown)comprising at least a power supply device, circuitry interconnectingsoftware-controllable electronic devices configured for at least one ofgenerating, transmitting, recording, processing, storing and reportingelectronic signals useful for manipulable modulation of the output fromthe power supply device for generation of laser light waves. The suctiondevice 90 is then placed onto a subject's body surface portion targetedto receive the lipolysis treatment so that the outward-facing surface ofthe molded lip 93 is in contact with the subject's skin. The vacuum pumpis then engaged thereby applying a suction force through the vacuum line96 and vacuum port 97 to the inner bowl area 92. The suction force drawsthe subject's body surface toward the base area of the molded bowl 91 sothat it is in close proximity to the laser diode 82 of thelaser-generating module 80. The laser control device is then manipulablyoperated to generate selected amounts of laser energy from the range of10 mW to 100 mW by the laser diode 82 for irradiation of the bodyportion that is drawn by the suction force within the inner bowl area92. The laser irradiation penetrates into the subcutaneous region ofdrawn-in body portion and liquefies solid and semi-solid fats in theadipose cells therein. The suction force exerted on the body portionfacilitates the movement of the liquefied fat from the adipose cellsinto the interstitial spaces from where it is absorbed into thelymphatic system and removed from the body portion by the subject'snormal physiological processes. It is suitable for an operator tomanipulate the vacuum suction device 90 while it is cooperating with thelaser-generating module 80, about a subject's body surface workingtoward the groin area and/or the armpit areas, where those skilled inthese arts know that a great abundance of lymphatic vessels aresituated, thereby enhancing removal of the liquefied fats from theinterstitial areas receiving the lipolysis treatments as describedherein.

At least one optional pressure-release aperture 101 may be providedtherethrough the molded body 91 to enable an operator to exertmanipulable manual control of the partial release of the suction forcegenerated by the suction device 90 during operation, by engaging anddisengaging one of their fingers with the pressure-release aperture 101.The shape of the pressure-release aperture 101 may be circular, oval,rectangular and suitably sized. The pressure-release aperture 101enables an operator to position the suction device 90 with a targetportion of a subject's body surface, then engage the vacuum pump 100 andthe and the laser control device and finally engage one of their fingerswith the pressure-release aperture 101 thereby applying a suction forceto the target portion of the subject's body surface. The operator maythen easily move the vacuum suction device 90 to another target portionof the subject's body surface by partially releasing the suction forcefrom within the suction device 90 by removing their finger from thepressure-release aperture 101, then sliding the vacuum suction device 90along the subject's body surface to the next target portion, and thenre-applying the suction force by re-engaging their finger with thepressure-release aperture 101. Those skilled in these arts willunderstand that the an operator may affect and control the movement ofliquefied fat from within the adipose cells into the interstitialspaces, and then about the subcutaneous region underlying the bodysurface by controllably applying and releasing by engaging anddisengaging their finger with the pressure-release aperture 101, thesuction force generated within vacuum suction device 90 whilecontrollably moving the vacuum suction device 90 about the subject'sbody surface. For example, using this method as described, the liquefiedfat may be thus manipulably moved from a subject's target body portionsto their groin area ore alternatively to an armpit, where lymphaticvessels are abundant and will thereby remove the liquefied fat via thesubject's physiological processes.

It is also within the scope of the present invention as exemplified inFIG. 8 to provide one or more relays 120 communicating with a vacuumpump 110 via vacuum line 115, and further interconnected and cooperatingwith two or more laser applicator systems as exemplified in FIGS. 6 and7. For example, a suitable exemplary configuration comprises two laserapplicator systems interconnected by a single relay to one vacuum pumpand a laser control device. This configuration makes it possible for anoperator to controllably and manipulably provide lipolysis treatments toa subject using two laser applicators of the present invention. Anothersuitable exemplary configuration is providing additional vacuum lines115′, 115″ communicating with a plurality of relays 120′, 120″interconnected with two or more subject treatment rooms with vacuumlines 98″, 98″′, 98′^(v), 98 ^(v), each containing at least one laserapplicator system and a control device of the present invention. Thisconfiguration makes it possible for two or more operators to provideconcurrently lipolysis treatments to multiple subjects, using the laserapplication systems of the present invention interconnected andcooperating with one central vacuum pump.

Another exemplary laser applicator system according to the presentinvention is illustrated in FIGS. 9 and FIGS. 10A, 10B, and 10C andgenerally comprises at least one first laser applicator 210 providedwith a plurality of low-power laser diodes, at least one second laserapplicator 220 provided with one laser diode, and a laser control device230 configured for controllably communicating and cooperating with thelaser applicators 210, 220. The first laser applicator generallycomprises a housing 211 configured to contain and retain a contact plate14 fitted and cooperating with a plurality of laser diodes 215. Thecontact plate 214 is configured to contact a portion of a subject's bodysurface. Suitable laser diodes are exemplified by multi-channel AlGaLnPlaser diodes configured for continuous and modulated continuous poweroutputs in the range of about 130 mW to about 170 mW of light waves inthe range of about 630 nm to about 680 nm with a modulation frequency of0 to about 10 Hz. It is suitable for the first laser applicator 210 tobe hardwired-connected to the laser control device 230. Alternatively,the first laser applicator 210 may be provided with a female electricalreceptacle (not shown) configured for releasably engaging male plug lead216 connected to the laser control device 230 by a suitable gauge wire217. The second laser applicator 220 is configured to cooperate andcommunicate with one suitable laser diode. As exemplified in FIGS. 10A,10B, and 10C, the second laser applicator comprises a housing 221 havinga generally elongate concave surface 222 configured for contacting asubject's body surface with a laser diode receptacle 223 extending awayfrom the concave surface 222 of the housing 221. An aperture 224communicating with the laser diode receptacle is provided about centerof the concave surface for transmitting laser light therethrough. Asuitable laser diode for the second laser applicator is exemplified by amulti-channel AlGaLnP laser diode configured for continuous andmodulated continuous power outputs in the range of about 0 mW to about50 mW of light waves in the range of about 630 nm to about 680 nm with amodulation frequency of 0 to about 10 Hz. It is suitable for the secondlaser applicator 220 to be connected to the laser control device 230with a suitable gauge wire 227. The laser control device 230 comprises agraphical user interface (GUI), a visual display unit 231, suitable userinput electronic devices 232 configured for communicating andcooperating with power modulation hardware, and suitably configuredsoftware. Although reference is made herein to interconnecting theexemplary laser applicators 210 and 220 with the exemplary laser controldevice with wires 217, 227, it is within the scope of the presentinvention to configure the laser applicators 210, 220 and the lasercontrol device 230 with provide wireless transmission/reception devicesfor cooperatively controllably generating laser light waves and energyfor application of lipolysis treatments to a subject's body surface.

Exemplary methods for the use of the laser applicators in cooperationwith the laser control devices of the lipolysis systems of the presentinvention are illustrated in FIGS. 11A, 11B, 11C, 12A, 12B, 12C, 13A,13B, 13C, 14A, 14B, 14C, 14D, 15A, 15B, 15C, and 15D. For example, asuitable method for liquefaction of subcutaneous fats about a subject'swaistline and for concurrent removal of the liquefied fats from thatarea of the of the subject's body is illustrated in FIGS. 11A, 11B, and11C. As shown in FIG. 11A, at least two first laser applicators 210 arefirst positioned next to each other on the right side of the subject'sbody about the right lateral waistline and secured in place with asuitable device (not shown) as exemplified by adhesive strips, elasticband, adjustable belt, adjustable strap and the like. At least onesecond laser applicator 220 is positioned approximate the upper inguinaljoint area defining the connection of each upper thigh with the bodytorso after which both laser applicators 220 are secured in place with asuitable device as exemplified by adhesive strips, elastic bands and thelike. The laser control device (not shown in FIGS. 11A, 11B, or 11C) isthen manipulated to provide about 10 to about 30 minutes of a firstlaser irradiation to the body surfaces contacting the laser applicators210, 220 and the underlying subcutaneous regions for liquefaction offats in adipose cells therein. At the conclusion of the first laserirradiation period, the at least two first laser applicators are movedto a second position about the medial waistline in the middle of thesubject's torso shown as 210′ in FIG. 11B and then secured in place.Each second laser applicator is moved downward along the inguinal jointarea defining the connection of each upper thigh with the body torso toabout the mid-point of the joint area shown as 220′ in FIG. 11B and thenis secured in place. The laser control device is then manipulated toprovide about 10 to about 30 minutes of a second laser irradiation tothe body surfaces contacting the laser applicators in the 210′ and 220′positions and the underlying subcutaneous regions for liquefaction offats in adipose cells therein. At the conclusion of the second laserirradiation period at least two first laser applicators are moved to athird position about the left lateral waistline of the subject's torsoas shown as 210″ in FIG. 11C and then secured in place. Each secondlaser applicator is moved downward along the inguinal joint areadefining the connection of each upper thigh with the body torso to aboutthe lower end of the inguinal joint area shown as 220″ in FIG. 11C andthen is secured in place. The laser control device is then manipulatedto provide about 10 to about 30 minutes of a third laser irradiation tothe body surfaces contacting the laser applicators in the 210″ and 220″positions and the underlying subcutaneous regions for liquefaction offats in adipose cells therein. At the conclusion of the third laserirradiation period the first and second laser applicators are removedand if so desired, employed for further lipolysis treatments elsewhereon the subject's body surface. It is to be noted that laser irradiationprovided by the second laser applicators 220 positioned about theinguinal joint areas will stimulate the lymph glands and associatedlymph vessels located in the subcutaneous areas of the inguinal jointareas and thus facilitate movement of liquefied fat from thesubcutaneous regions underlying the portions of the body surfacereceiving laser irradiation from the first laser applicators 210, willfacilitate its movement to the lymph glands and its subsequent removalfrom those areas by the lymphatic system.

FIGS. 12A, 12B, and 12C are schematic illustrations of exemplarypositioning of the laser applicators about a subject's body torso forliquefaction of fats about their abdominal oblique muscle areas. Asshown in FIG. 12A, at least two first laser applicators 210 are firstpositioned next to each other about the upper lateral oblique area ofthe subject's body torso and secured in place with a suitable device(not shown) as exemplified by adhesive strips, elastic band, adjustablebelt, adjustable strap and the like. At least one second laserapplicator 220 is positioned approximate the upper inguinal joint areadefining the connection of each upper thigh with the body torso afterwhich both laser applicators 220 are secured in place with a suitabledevice as exemplified by adhesive strips, elastic bands and the like.The laser control device (not shown in FIGS. 12A, 12B, or 12C) is thenmanipulated to provide about 10 to about 30 minutes of a first laserirradiation to the body surfaces contacting the laser applicators 210,220 and the underlying subcutaneous regions for liquefaction of fats inadipose cells therein. At the conclusion of the first laser irradiationperiod, the at least two first laser applicators are moved to a secondposition about the middle oblique area of the subject's body torso shownas 210′ in FIG. 12B and then secured in place. Each second laserapplicator is moved downward along the inguinal joint area defining theconnection of each upper thigh with the body torso to about themid-point of the joint area shown as 220′ in FIG. 12B and then issecured in place. The laser control device is then manipulated toprovide about 10 to about 30 minutes of a second laser irradiation tothe body surfaces contacting the laser applicators in the 210′ and 220′positions and the underlying subcutaneous regions for liquefaction offats in adipose cells therein. At the conclusion of the second laserirradiation period at least two first laser applicators are moved to athird position about the lower oblique area of the subject's torso asshown as 210″ in FIG. 12C and then secured in place. Each second laserapplicator is moved downward along the inguinal joint area defining theconnection of each upper thigh with the body torso to about the lowerend of the inguinal joint area shown as 220″ in FIG. 12C and then issecured in place. The laser control device is then manipulated toprovide about 10 to about 30 minutes of a third laser irradiation to thebody surfaces contacting the laser applicators in the 210″ and 220″positions and the underlying subcutaneous regions for liquefaction offats in adipose cells therein. At the conclusion of the third laserirradiation period the first and second laser applicators are removedand if so desired, employed for further lipolysis treatments elsewhereon the subject's body surface. It is to be noted that laser irradiationprovided by the second laser applicators 220 positioned about theinguinal joint areas will stimulate the lymph glands and associatedlymph vessels located in the subcutaneous areas of the inguinal jointareas and thus facilitate movement of liquefied fat from thesubcutaneous regions underlying the portions of the body surfacereceiving laser irradiation from the first laser applicators 210, willfacilitate its movement to the lymph glands and its subsequent removalfrom those areas by the lymphatic system.

FIGS. 13A, 13B, and 13C are schematic illustrations of exemplarypositioning of the laser applicators about a subject's body torso forliquefaction of fats about their upper abdominal areas. As shown in FIG.13A, at least two first laser applicators 210 are first positioned nextto each other about the upper abdomen area on the right side of thesubject's body and secured in place with a suitable device (not shown)as exemplified by adhesive strips, elastic band, adjustable belt,adjustable strap and the like. At least one second laser applicator 220is positioned approximate the upper inguinal joint area defining theconnection of each upper thigh with the body torso after which bothlaser applicators 220 are secured in place with a suitable device asexemplified by adhesive strips, elastic bands and the like. The lasercontrol device (not shown in FIGS. 13A, 13B, or 13C) is then manipulatedto provide about 10 to about 30 minutes of a first laser irradiation tothe body surfaces contacting the laser applicators 210, 220 and theunderlying subcutaneous regions for liquefaction of fats in adiposecells therein. At the conclusion of the first laser irradiation period,the at least two first laser applicators are moved to a second positionabout the middle upper abdomen area of the subject's body torso shown as210′ in FIG. 13B and then secured in place. Each second laser applicatoris moved downward along the inguinal joint area defining the connectionof each upper thigh with the body torso to about the mid-point of thejoint area shown as 220′ in FIG. 13B and then is secured in place. Thelaser control device is then manipulated to provide about 10 to about 30minutes of a second laser irradiation to the body surfaces contactingthe laser applicators in the 210′ and 220′ positions and the underlyingsubcutaneous regions for liquefaction of fats in adipose cells therein.At the conclusion of the second laser irradiation period at least twofirst laser applicators are moved to a third position about the upperabdomen area on the right side of the subject's body as shown as 210″ inFIG. 13C and then secured in place. Each second laser applicator ismoved downward along the inguinal joint area defining the connection ofeach upper thigh with the body torso to about the lower end of theinguinal joint area shown as 220″ in FIG. 13C and then is secured inplace. The laser control device is then manipulated to provide about 10to about 30 minutes of a third laser irradiation to the body surfacescontacting the laser applicators in the 210″ and 220″ positions and theunderlying subcutaneous regions for liquefaction of fats in adiposecells therein. At the conclusion of the third laser irradiation periodthe first and second laser applicators are removed and if so desired,employed for further lipolysis treatments elsewhere on the subject'sbody surface.

FIGS. 14A, 14B, 14C, and 14D are schematic illustrations of exemplarypositioning of the laser applicators about a subject's body torso forliquefaction of fats about their upper thigh areas. As shown in FIG.14A, one first laser applicator 210 is positioned on the subject's rightupper thigh adjacent a vertical linear axis extending upward from theright knee while a second first applicator 210 is positioned on thesubject's left upper thigh adjacent a vertical linear axis extendingupward from the left knee. Both first laser applicators are secured inplace with a suitable device (not shown) as exemplified by adhesivestrips, elastic band, adjustable belt, adjustable strap and the like. Atleast one second laser applicator 220 is positioned approximate themid-portion area of the inguinal joint area defining the connection ofeach upper thigh with the body torso as shown in FIG. 14D after whichboth laser applicators 220 are secured in place with a suitable deviceas exemplified by adhesive strips, elastic bands and the like. The lasercontrol device (not shown in FIGS. 14A, 14B, 14C, or 14D) is thenmanipulated to provide about 10 to about 30 minutes of a first laserirradiation to the body surfaces contacting the laser applicators 210,220 and the underlying subcutaneous regions for liquefaction of fats inadipose cells therein. At the conclusion of the first laser irradiationperiod, the first laser applicator 210 is re-positioned on the subject'sright upper thigh to a position facing the left upper thigh while thesecond first applicator 210 is re-positioned on the subject's left upperthigh adjacent to a position facing the right upper thigh as shown inFIG. 14B, and both are secured in place. The two second laserapplicators are maintained in the same position shown in FIG. 14D. Thelaser control device is then manipulated to provide about 10 to about 30minutes of a second laser irradiation to the body surfaces contactingthe laser applicators in the 210′ and 220′ positions and the underlyingsubcutaneous regions for liquefaction of fats in adipose cells therein.At the conclusion of the second laser irradiation period, the firstlaser applicator 210 is re-positioned on the subject's right upper thighto a backward-facing position while the second first applicator 210 isre-positioned on the subject's left upper thigh to a similarbackward-facing position as shown in FIG. 14C, and both are secured inplace. The two second laser applicators are maintained in the sameposition shown in FIG. 14D. The laser control device is then manipulatedto provide about 10 to about 30 minutes of a third laser irradiation tothe body surfaces contacting the laser applicators in the 210″ and 220″positions and the underlying subcutaneous regions for liquefaction offats in adipose cells therein. At the conclusion of the third laserirradiation period the first and second laser applicators are removedand if so desired, employed for further lipolysis treatments elsewhereon the subject's body surface.

FIGS. 15A, 15B, 15C, and 15D are schematic illustrations of exemplarypositioning of the laser applicators about a subject's body torso forliquefaction of fats about their lower back areas. As shown in FIG. 15A,at least two first laser applicators 210 are first positioned next toeach other on the left side of the subject's body about the hip area andsecured in place with a suitable device (not shown) as exemplified byadhesive strips, elastic band, adjustable belt, adjustable strap and thelike. At least one second laser applicator 220 is positioned approximatethe upper inguinal joint area defining the connection of each upperthigh with the body torso as shown in FIG. 15D after which both laserapplicators 220 are secured in place with a suitable device asexemplified by adhesive strips, elastic bands and the like. The lasercontrol device (not shown in FIGS. 15A, 15B, 15C, or 15D) is thenmanipulated to provide about 10 to about 30 minutes of a first laserirradiation to the body surfaces contacting the laser applicators 210,220 and the underlying subcutaneous regions for liquefaction of fats inadipose cells therein. At the conclusion of the first laser irradiationperiod, the at least two first laser applicators are moved to a secondposition about the above the hip area in the middle of the subject'storso shown as 210′ in FIG. 15B and then secured in place. Each secondlaser applicator is moved downward along the inguinal joint areadefining the connection of each upper thigh with the body torso to aboutthe mid-point of the joint area shown as 220′ in FIG. 15D and then issecured in place. The laser control device is then manipulated toprovide about 10 to about 30 minutes of a second laser irradiation tothe body surfaces contacting the laser applicators in the 210′ and 220′positions and the underlying subcutaneous regions for liquefaction offats in adipose cells therein. At the conclusion of the second laserirradiation period at least two first laser applicators are moved to athird position about on the right side of the subject's body about thehip area as shown as 210″ in FIG. 15C and then secured in place. Eachsecond laser applicator is moved downward along the inguinal joint areadefining the connection of each upper thigh with the body torso to aboutthe lower end of the inguinal joint area shown as 220″ in FIG. 15D andthen is secured in place. The laser control device is then manipulatedto provide about 10 to about 30 minutes of a third laser irradiation tothe body surfaces contacting the laser applicators in the 210″ and 220″positions and the underlying subcutaneous regions for liquefaction offats in adipose cells therein. At the conclusion of the third laserirradiation period the first and second laser applicators are removedand if so desired, employed for further lipolysis treatments elsewhereon the subject's body surface.

Those skilled in these arts will understand that the exemplary methodsshown in FIGS. 11A, 11B, 11C, 12A, 12B, 12C, 13A, 13B, 13C, 14A, 14B,14C, 14D, 15A, 15B, 15C, and 15D for the use of lipolysis systems toapply lipolysis treatments to a subject's body surface may be suitablymodified to personalize the methods to individual subjects. For example,the lipolysis treatments about a certain body portion e.g., such as thewaist area and the lower back area, may be applied in the reverse orderto that described. Also, the exemplary methods are applicable to allareas about a subject's body torso and their extremities. Also, asuitable duration of laser irradiation applied to each body portion maybe selected based on a target amount of fat liquefaction desired foreach target body portion. Furthermore, those skilled in these arts willunderstand that the laser applicators, the lipolysis systems and themethods for their use according to the present invention may be employedfor body sculpting, contouring and toning by: (a) selection of thenumbers of first and second laser applicators used for each lipolysistreatment, and (b) by selecting specific combinations of body torso andextremity target surface areas for each lipolysis treatment. Forclarity, lipolysis treatment in this context means a combination ofthree time-selected laser irradiations applied to one or more bodysurface areas during one lipolysis treatment session. For example, anexemplary sixty-minute lypolysis treatment session may comprise threeten-minute laser irradiations about a subject's waistline area followedby three ten-minute laser irradiations about their upper abdomen area,or alternatively, by three ten minute laser irradiations about theirlower back area. An exemplary 120-minute lipolysis treatment session maycomprise two sets of three ten-minute laser irradiations about asubject's body torso followed by a set of three ten-minute laserirradiations about their upper thigh areas and a set of ten-minuteirradiations about their upper arms.

It is within the scope of the present invention to combine the laserapplicators, lipolysis systems comprising the laser applicators, and themethods for their use as exemplified herein, with other suitable devicesand apparatus configured for a subject's use for physical exercising.Such suitable physical exercising devices and apparatus includeequipment commonly referred to as “whole body vibration” devices thatare provided with an exercise platform or surface, configured to providecontrollable vibrations to a subject positioned thereon. Suitable wholebody vibration devices are exemplified by the Soloflex® WBV® vibratingexercise platform (Soloflex and Soloflex WBV are registered trademarksof Soloflex Inc., Hillsboro, Oreg., USA), the Nobelrex K1 and K2machines (Nobelrex K-1 Ltd., OR, USA), the Power Plate® pro5 machines(Power Plate is a registered trademark of Power Plate North AmericaLtd., Northbrook Ill. USA), the VibePlate® platforms (VibePlate is aregistered trademark of VibePlate Inc., Lincoln Nebr., USA) and thelike. An exemplary method for combining the use of the laser applicatorsand lipolysis systems comprising the laser applicators of the presentinvention comprises securing to a target portion of a subject's bodysurface, at least one laser applicator configured as described hereinand cooperatively communicating with a suitable laser control devise asprovided with a lipolysis system of the present invention, after whichthe subject mounts a whole body vibration device in a suitable position.The laser irradiation treatment is then provided for a selected periodof time concurrent with the delivery of vibrations to the subject by thewhole body vibration device. At the conclusion of the laser irradiationtreatment, the subject demounts from the whole body vibration device forre-positioning of the at least one applicator, after which, the subjectremounts the whole body vibration machine for an addition period ofconcurrent delivery of laser irradiation from the laser applicator andvibrations from the whole body vibration device. The subject mayselectively receive: (a) concurrent laser irradiation and whole bodyvibrations, or (b) laser irradiation only, or (c) whole body vibrationsonly during the course of a lipolysis treatment session with thelipolysis system of the present invention. Those skilled in these artswill understand that combining whole body vibration treatments fromwhole body vibration devices concurrent with lipolysis treatments by thelipolysis systems of the present invention will facilitate and enhancemovement of liquefied fats from within adipose cells into theinterstitial spaces, and from the interstitial spaces into the groinarea where they are absorbed into the lymphatic system which will thentransport the liquefied fats away from the groin area for furtherprocessing and elimination by the subject's normal physiologicalprocesses.

It is within the scope of the present invention to combine the laserapplicators, lipolysis systems comprising the laser applicators, and themethods for their use as exemplified herein, with other types ofnon-surgical cosmetic treatments commonly employed for dissolving fatsand cellulose and referred to by those skilled in these arts asmesotherapy and lipodissolve treatments. Mesotherapy typically involvesmultiple injections of pharmaceutical compositions and/or homeopathiccompositions, and or plant extracts and/or vitamins into subcutaneousregions of a subject's body having protuberances caused by fataccumulations, while lipodissolve treatments typically involve multipleinjections of phosphatidylcholine deoxycholate (PCDC) into the sametarget areas that mesotherapy is delivered. Mesotherapy and lipodissolvetreatments are purported to cause lysis of adipose cells that are thenremoved from the body via its normal physiological functioning. Thoseskilled in these arts will understand that mesotherapy and lipodis solvetreatments can be provided in combination with lipolysis treatments withthe laser applicators and lipolysis systems of the present invention.For example, a series of PCDC injections can be subcutaneouslyadministered to targeted portions of a subject's body surface. At leastone or alternatively, a plurality of laser applicator according to thepresent invention can then be secured to an injection site forapplication of laser irradiation thereto with the lipolysis system ofthe present invention. It is suitable to secure a first laser applicatorcomprising a plurality of laser diodes, to an injection site and toconcurrently secure a second laser applicator comprising a single laserdiode, to a site about the inguinal joint area.

The examples presented below are included as embodiments of the presentinvention, but are not intended to limit the scope of the presentinvention.

The example presented below is included as an exemplary embodiment ofthe present invention, but is not intended to limit the scope of thepresent invention.

EXAMPLE 1

Methods:

(a) Clinical Trial:

Forty healthy men and women between the ages of 18-65 years of ageinclusive with a body mass index (BMI) no greater than 29.9 kg/m² wererandomized in a 1:1 ratio to an experimental laser treatment or to acontrol laser treatment. Randomization was created from random numbertables and the treatment codes were stored in sealed envelopes duringthe study. Subjects could not be using light sensitizing agents,undergoing photodynamic therapy or using diuretics. Subjects wererequired to have a stable weight, gaining or losing no more than 2.5 kgin the 6 months prior to the trial. Subjects could not be on a weightreduction regimen, and they were asked not to change their diet orexercise habits during the trial.

An exemplary lipolysis system of the present invention similar to thesystem illustrated in FIG. 9 was employed for the clinical trial andcomprised two laser applicators each provided with four low-power laserdiodes (multi-channel AlGaLnP laser diodes configured for continuous andmodulated continuous power outputs in the range of about 130 mW to about170 mW of light waves in the range of about 630 nm to about 680 nm witha modulation frequency of 0 to about 10 Hz), and a laser control deviceconfigured for controllably communicating and cooperating with the twolaser applicators. Each subject received two treatments per week for atotal of eight treatments over four weeks. Each treatment session lastedapproximately thirty minutes. The two laser applicators were placed overthe waist bilaterally in three positions and the laser was activated forten minutes in each of these positions to encompass the waist from theback to the front. Two operators conducted each treatment sessionthroughout the study. One operator administered the treatment, and theother operator, who was blinded to treatment allocations, obtainedmeasurements and photographs. The operator administering the treatmentremained blinded to photographic and girth measurements. Each subjectwas advised about the rules of blinding, and individual takingphotographs and measurements could not relay this information to thesubject. The operator administering the treatment did not enter the roomwhere the photographs and measurements were obtained. A new Case ReportForm was used for each measurement session and these forms were placedin a sealed envelope until data was analyzed at the end of the study. Aseparate person who was not involved in other aspects of the study didthe blinded evaluations of the photographs.

All subjects had photographs taken at a standardized distance withstandard background and lighting. Girth measurements of the waist wereobtained in the manner recommended by the United States NationalInstitutes of Health National Institute for Health guidance (NIH) at theiliac crest using a tape measure with standardized tension and parallelto the floor following the protocol outlined in the journal ObesityResearch, 1998, Sep;6 Suppl. 2: 51S-209S (no authors listed). Areference point on the body for the pictures and measurements wasrelocated at each evaluation by measuring a distance from the floor thatwas determined in the first measurement at baseline. The specifiedmeasured distance was used to ensure all measurements and photographsare obtained in the same location. The camera was placed on a tripod ata fixed distance from the floor, but was adjusted to a specific heightof each individual participant. Standardized waist measurements weretaken at baseline, treatment session #3 and treatment session #8.Standardized photographs were taken before an after the initialtreatment, t treatment session #3 and treatment session #8. Weight wasmeasured and BMI calculated at baseline and at treatment session #8(week 4). Blood pressure was measured at baseline, treatment session #3and treatment session #8. Any adverse events were noted in the casereport forms.

(b) In Vitro Study Using Human Fat Cells

Human fat cells were prepared in two 12-well plates. Three of the cellsin the plates were left as a control. Fresh plasma replaced one third ofthe cell culture media in another three wells. The next three wells hadone third of the media replaced with fresh human white cells insuspension. The final three wells in each plate had one third of themedia replaced by a combination of fresh human plasma and white bloodcells. One of the plated was irradiated for ten minutes with a laserapplicator comprising 4 laser diodes (multi-channel AlGaLnP laser diodesconfigured for continuous and modulated continuous power outputs in therange of about 130 mW to about 170 mW of light waves in the range ofabout 630 nm to about 680 nm with a modulation frequency of 0 to about10 Hz), and the other was left as a non-irradiated control. Theconditioned media from the four types of wells from each plate weretested for membrane attack complexes of complement (MAC) using an ELISAassay.

Results:

(a) Clinical Trial

The groups were well balanced at baseline, and the group characteristicsare illustrated in Table 1. Weight and BMI did not change significantlyover the 8 treatments and 4 weeks. Blood pressure did not changesignificantly from baseline to treatment 3, from treatment 3 totreatment 8 or from baseline to treatment 8. Each treatment with theLipoLaser gave an approximate loss of 0.4 cm to 0.5 cm in waist girth.This difference, 0.405 cm (Laser −0.59±0.708 cm vs. Placebo −0.19±0.47cm (mean ±SD), was significant (p<0.05) on the third treatment sessiondone during week two on the completers analysis, but was notstatistically significant by the intent to treat analysis. Thecumulative girth loss at treatment session #3 on week two was asignificant 1.74 cm

TABLE 1 Clinical trial participant data Variable Lipoloysis GroupPlacebo Group P-Value Number enrolled 20 20 Gender 0.0765 Female 19 15Male 1 5 Age (Years) 35.1 38.35 0.3292 SD 9.11 11.55 Weight (kg) 63.9767.31 0.3705 SD 8.23 14.31 Height (cm) 164.12 165.68 0.5341 SD 5.99 9.32Body Mass Index (kg/m²) 23.77 24.35 0.4641 SD 2.02 2.87 SBP 120.15121.40 0.7330 SD 11.98 11.00 DBP 75.35 75.00 0.8922 SD 8.23 8.00 Valuesare means and standard deviation (SD)

(Laser −1.895±2.967 cm vs. Placebo −0.16±2.458 cm) (p<0.05) on both thecompleters analysis and by intent to treat analysis. Cumulative girthloss at treatment session #8 (4 weeks of treatment) was 2.15 cm (Laser−0.781 ±2.817 cm vs. Placebo 1.353±2.644 cm) in those who maintainedtheir weight within 1.5 kg of their baseline weight (p<0.05). Thestandardized pictures of the participants showed a significant 1.21difference (Laser 1.21±0.419 vs. Placebo 0±0 cm) in appearance on a 0-3scale favoring the LipoLaser group comparing the baseline to the week 4(treatment 8) pictures (p<0.001). When only those participants thatremained within 1.5 kg of their baseline weight were considered, theimprovement in appearance increased to 1.25 (Laser 1.25±0.447 vs.Placebo 0±0) on a 0-3 scale comparing the baseline to the week 4(treatment session #8) pictures (p<0.001). Girth losses in the laser andplacebo groups at the various time points are illustrated in FIG. 16.The girth difference in the Laser group compared to the placebo group isillustrated in FIG. 17. The differences in appearance from baseline toweek 4 (treatment session #8) in the whole group and the subjects whoremained within 1.5 kg of their baseline weight are illustrated in FIG.18. (One subject withdrew from the study due to scheduling conflicts.The individual was in the treatment group, and lost 0.2 cm in waistgirth with the initial treatment prior to withdrawing).

(b) In Vitro Study Using Human Fat Cells

The human fat cells in the non-laser treated 12-well plate remainedintact. The human fat cells in culture media treated with the laserremained intact, as did the human fat cells treated with the laser inthe presence of fresh human white blood cells. The fat cells treated inthe presence of fresh human serum or fresh human serum combined withfresh human white blood cells released their fat. The MAC was present inboth of the conditions in which the wells were treated with the laser inthe presence of human serum or human serum with white blood cells.

Discussion:

A single lipolysis treatment session provided by an exemplary lipolysissystem of the present invention was effective in providing giving girthloss, and repeated treatment sessions further provided between 0.4 to0.5 cm girth loss per treatment session. This difference wasstatistically significant at treatment session #3 demonstrating that theeffect of the lipolysis system of the present invention does not appearto diminish with repeated treatments through time. The 1.74 cm girthloss at treatment session #3 suggests that the methods of use of thelipolysis systems as described herein are cumulative in their effect ongirth loss.

It is obvious that weight change over the course of treatment wouldchange waist circumference and confound the results. The subjectsselected for the study were asked not to lose or gain weight over thecourse of the study. Since some subjects did gain or lose a significantamount of weight over the 4 week study, the cumulative fat loss wasanalyzed only on those subjects whose weight was within 1.5 kg of theirbaseline weight. The selection of a 1.5 kg limit for weight fluctuationwas based on the fact that this study was the length of a 4-weekmenstrual cycle minimizing the effect of menstrually-related fluidshifts in women (Robinson et al., 1965, Brit. J. Nutr. 19: 225-235).

Girth loss over the course of the study was greater than 2 cm andstatistically significant. The subjects in this study were not obese andan approximate 1 inch (2.54 cm) reduction in waist girth over the courseof 8 treatment sessions over a 4-week period was clinically significant.The blinded ratings of the baseline pictures compared to the treatmentsession #8 (week 4) pictures taken in a standardized way demonstrated animprovement in appearance that was highly statistically significant. Asexpected, the improvement was greater when limiting the comparison toonly those subjects that remained within 1.5 kg of their baselineweight.

Thus, the laser applicators, lipolysis systems comprising the laserapplicators, and methods for their use provide significant waist girthloss that is sustained over repeated treatments and is cumulative over 4weeks of 8 treatments. This waist girth loss was almost one inch (2.54cm) in magnitude. Therefore, the exemplary embodiments of the presentinvention disclosed herein provided both a clinically and statisticallysignificant improvement in appearance.

While the exemplary laser applicators and lipolysis systems of thepresent invention have been described with low power laser diodesconfigured to produce power outputs in the range comprising about 10 mWto about 100 mW with light waves in the range of 635 nm to 680 nm, it isalso within the scope of the present invention to provide laserapplicators and laser applicator systems configured with combinations oflow power laser diodes and medium power laser diodes having poweroutputs in the range of about 80 mW to about 160 mW with light waves inthe range of 780 nm to 980 nm.

Although the present invention has been described with reference tocertain exemplary embodiments thereof, in view of numerous changes andvariations that will be apparent to persons skilled in the art, thescope of the present invention is to be considered limited solely by theappended claims.

1. A laser applicator configured for contacting a portion of a subject'sbody surface and controllably applying a laser irradiation thereto forthe purpose of liquefying fats in adipose cells in the subcutaneousregion underlying the contacted portion of the body surface, the laserapplicator comprising at least one laser diode selected for emission ofpower outputs in the range comprising about 10 mW to about 150 mW withlight waves in the range of 635 nm to 680 nm, said laser applicatorcommunicable and cooperable with a laser control device.
 2. A laserapplicator according to claim 1, wherein the laser applicator comprisesa plurality of laser diodes, each laser diode selected for emission ofpower outputs in the range comprising about 10 mW to about 150 mW withlight waves in the range of 635 nm to 680 nm. 3-16. (canceled)
 17. Amethod for liquefying fats in a subject's adipose cells in subcutaneousregions underlying their body surfaces using the laser applicator ofclaim 1, the method comprising: a first step of contacting at least onetarget portion of the subject's body surface with the laser applicator;and a second step of controllably irradiating the at least one targetportion with laser wavelengths for a selected period of time.
 18. Amethod according to claim 17, wherein the first step and second step arerepeated at least once during a treatment session. 19-20. (canceled) 21.A lipolysis system configured for concurrently contacting andcontrollably providing low-power laser irradiation to a plurality oftargeted portions of a subject's body surface for the purpose ofliquefying fats in adipose cells in subcutaneous regions underlying thetargeted body surface portions; the lipolysis system comprising: a firstlaser applicator configured to contact a subject's body surface forproviding laser irradiation thereto, the first laser applicatorcomprising a plurality of low-power laser diodes; a second laserapplicator configured to contact a subject's body surface for providinglaser irradiation thereto, the second laser applicator comprising atleast one low-power laser diode; and a laser control device configuredfor controllably communicating and cooperating with said first laserapplicator and said second laser applicator.
 22. A lipolysis systemaccording to claim 21, provided with a plurality of said first laserapplicators, and with a plurality of said second laser applicators. 23.A lipolysis system according to claim 21, wherein the first laserapplicator comprises a laser diode selected for emission of poweroutputs in the range comprising about 10 mW to about 100 mW with lightwaves in the range of 635 nm to 680 nm.
 24. A lipolysis system accordingto claim 22, wherein the first laser applicator comprises at least onelow-power laser diode selected for emission of power outputs in therange comprising about 10 mW to about 100 mW with light waves in therange of 635 nm to 680 nm, and at least one laser diode selected foremission of power outputs in the range comprising about 80 mW to about160 mW with light waves in the range of 780 nm to 980 nm. 25-40.(canceled)